MediciNova , in partnership with researchers at the University of California, Los Angeles (UCLA), US, is set to begin a clinical trial to investigate MN-166 (ibudilast) as a potential treatment for individuals diagnosed with alcohol use disorder (AUD).
The randomised, outpatient trial aims to enrol 50 non-treatment seeking individuals with moderate-to-severe AUD.
The trial will be funded by the Center for Study of Opioid Receptors and Drugs of Abuse (CSORDA), and will identify whether MN-166 is more effective for those patients who experience withdrawal-related dysphoria than those who do not experience withdrawal.
During the trial, the subjects will be stratified based on presence or absence of withdrawal-related dysphoria and will be randomly assigned to a 14-day treatment period to receive repeated oral doses of either MN-166 escalated up to 100mg/day or placebo.
The study researchers will conduct Ecological Momentary Assessment (EMA) each day, a research technique which allows the examination of dynamic processes associated with depression and depression-related phenomena.
Throughout the treatment, subjects will take MN-166 and will report on their alcohol craving, as well as mood surveys and standard safety tests.
The trial’s major outcomes include whether MN-166 minimises basal level negative affect during abstinence, and in doing so, will interfere with alcohol-induced blunting of negative affectivity as captured during naturalistic drinking episodes.
The study principal investigator Lara Ray said: “The interplay between affect, withdrawal, and response to MN-166 in this population is an intriguing one.”
MediciNova’s MN-166 is currently available in Japan and South Korea for the treatment of post-stroke complications and bronchial asthma.
The company aims to develop the solution for various neurological conditions, including progressive multiple sclerosis (MS), amyotrophic lateral sclerosis (ALS) and substance abuse disorder.
